PET Imaging in ALS Patients

NCT ID: NCT02236897

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-03-31

Brief Summary

This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET Scanning

Imaging of mGluR5 using PET scanning

Group Type: EXPERIMENTAL

PET Scanning

Intervention Type: OTHER

Interventions

PET Scanning

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female ALS patients, ranging in age from 18-80.
• Must meet El Escorial Criteria for Probable or Definite ALS.
• Disease duration >1 year, but <3 years.
• Weakness in at least two extremities.
• Forced vital capacity less than 80% and greater than 50%.

Exclusion Criteria

• Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.
• Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan.
• Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists.
• Significant abnormalities of hepatic or renal function, or illicit substance use.
• Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening).
• Weighs > 350 lbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Lyle W. Ostrow, MD, PhD

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lyle Ostrow, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00073452

Identifier Type: -

Identifier Source: org_study_id